Medical swabs are generally known in the art for use in collecting biological specimens from a patient for further analysis. Such medical swabs commonly comprise a fibrous swab tip at one end of an elongated stick or shaft, which is manipulated to contact the swab tip with selected tissue cells, secretions, fluids or other biological specimens obtained, for example, from within the ear, nose, throat, vaginal opening or other body cavity/opening of a patient. As a result, some of the targeted biological specimen adheres to the swab tip. The swab tip then can be contacted with one or more chemical reagents to indicate the presence of infection or other information regarding patient condition. Such reagent testing may either be quantitative in character, in that it produces a quantifiable result, qualitative (as providing matter of degree of infection or contamination by using a scale system), or a positive/negative-type test result, in that it indicates the presence of a particular condition, but does not provide details as to degree.
Alternatively, such swab testing may be used as part of environmental condition monitoring. For instance, such swabbing may be done in a food service area to determine the presence or absence of environmental or food pathogens or contaminants.
Such medical swabs may be either used as part of a storage/transport unit for transporting a biological sample to a laboratory for further analysis, or alternatively, as part of a portable test detection device, designed to provide an immediate or relatively quick indication of a patient's or environmental condition at the time of the test. If the swab is part of a storage/transport unit, it is likely that such unit will include growth media or other chemistries to aid in maintaining the specimen in a viable state during transport.
Tests commonly performed with such patient specimens include, by way of example, fluorescent tests, enzymatic tests, monoclonal based tests, agglutination tests, and others. Moreover, swabs and similar reagent test methods are also used in a variety of nonmedical applications to determine the presence of biological organisms on a selected surface, such as a food preparation surface in a restaurant, a slaughterhouse surface or the like.
In accordance with standard specimen collection and test preparation techniques, the biological specimen is normally transferred from the swab tip to a slide or other laboratory apparatus such as a test tube or the like, for contact with the selected reagent or reagents and further analysis. The reagents are typically stored in a vial or other breakable container prior to use. However, it is frequently difficult to ensure transfer of a sufficient specimen quantity from the swab tip to the laboratory slide or test tube to ensure accurate test results. Moreover, in many instances, the collected specimen must be transported to an off-site laboratory for performance of selected assays. Delays between the time of specimen collection and actual test performance can result in partial or complete drying of the specimen, with a corresponding decrease in test reliability. In addition, such conventional handling of a biological specimen in the course of preparing and/or performing an analysis undesirably exposes personnel to direct contact with the collected organism, wherein direct contact with infectious or toxic organisms can be especially undesirable.
In this regard, a variety of swab-type specimen collection and test devices have been proposed in efforts to provide enhanced contact between a specimen and reagents, or to sustain the specimen in an improved manner during transport to a laboratory, while at the same time reducing or minimizing risk of direct personnel contact with the collected specimen.
For example, sampling/test kits are now abundantly available for providing transport or testing of specimens in both a hospital and medical office environment. While these tests may be used in the home of a patient, the kits often involve multiple steps or stages, breakable parts, and in many cases, assembly, making them less desirable for use by the general public. For instance it is not unusual for a kit to include three to four parts such as a swab, a collection dish/tray or chamber, in some cases vials of testing solutions or reagents, and an assay medium such as a test strip. In test devices involving multiple pieces, the various components used to conduct the test must be kept separated in order to avoid possible contamination of either the testing substrate or the reagents/growth media used in the test.
Typically, such kits involve mixing of test solutions, or causing the rupture of a vessel containing the test solution(s), filling a testing dish, tray or vessel with the testing solutions (most often in the form of a small test tube or test chamber), placing the swab in the testing dish, tray or vessel, and either waiting for the results to be observed on a test strip or indicator, or alternatively for a value to be generated. In some instances, such kits also require the removal of the swab, or dipping a testing strip into a testing dish in order to obtain an analysis result. Depending on the type of kit being used, such steps may involve the awkward placement of test solution vials next to the test tray, or the continuous possibility of exposure of biological specimens to the tester.
Further, as many of such test kits utilize a relatively flexible bulbous vessel for dispensing test solutions/reagents directly into a test vessel, upon being squeezed (application of pressure) or upon having an internal component ruptured, such kits present the possibility of inadvertent rupturing of the vessel, or initiation of the test, when such is not desired. Such tests may also present the possibility of injury to the tester as internal components to be ruptured may include glass, reagent containing ampoules.
There is therefore a need for a simplified test device that can be conveniently stored safely in either the home, medical office or other commercial environments, and that requires minimal to no assembly (with few pieces) prior to use. There is a further need for a test device which provides an immediate visual indication readily to a user, of the results of such a test, but which cannot easily be inadvertently initiated or compromised. There is also a further need for a test device which is relatively stable in use, and avoids the need for awkward solution storage vessels or breakable reagent-containing ampoules for operation.
Given the current rise in health care costs and a focus on preventative/preemptive medicine, the members of the general public are performing more preliminary medical testing in their home environments. Such medical testing allows the individual to make basic medical determinations (such as blood sugar levels, cholesterol levels, blood alcohol levels, pregnancy evaluations, and various urinalysis and breath analysis) prior to visiting a physician, offering vast potential savings in both dollars to the consumer, and in time for physicians who can devote more of their time to patients who truly require medical attention. There is therefore a need for diagnostic test devices which are “patient friendly”, in that they are easy to operate and relatively contained in their configuration, so as to allow for the efficient identification of possible medical conditions prior to the costly involvement of a medical practitioner. It is to such needs that the current invention is directed.
Finally, in the practice of gastrointestinal and gynecological medicine, numerous more invasive tests are performed in various internal body organs which require the taking of a specimen or sample/biopsy from an internal space. For instance, it is not uncommon for endoscopic procedures to be performed on patients in order to obtain specimens of stomach lining or stomach fluids, so as to detect ulcer-causing bacteria, or in the colon so as to obtain specimens to detect precancerous polyps, related fluids and the like. With such endoscopic procedures, it is not uncommon for the endoscopic devices to include brushes, forceps, snares or baskets to obtain specimens. The specimens from such procedures may then be sent off to a laboratory facility for further analysis. There is therefore a need for an endoscopic swab that could be used as part of a rapid diagnostic device (where appropriate) to detect a medical condition. It is also to such needs that the current invention is directed.